The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial

Background Hypertension is one of the most important cardiovascular disease risk factors and affects >100 million American adults. Hypertension-related health inequities are abundant in Black communities as Black individuals are more likely to use the emergency department (ED) for chronic disease–related ambulatory care, which is strongly linked to lower blood pressure (BP) control, diminished awareness of hypertension, and adverse cardiovascular events. To reduce hypertension-related health disparities, we developed MI-BP, a culturally tailored multibehavior mobile health intervention that targeted behaviors of BP self-monitoring, physical activity, sodium intake, and medication adherence in Black individuals with uncontrolled hypertension recruited from ED and community-based settings. Objective We sought to determine the effect of MI-BP on BP as well as secondary outcomes of physical activity, sodium intake, medication adherence, and BP control compared to enhanced usual care control at 1-year follow-up. Methods We conducted a 1-year, 2-group randomized controlled trial of the MI-BP intervention compared to an enhanced usual care control group where participants aged 25 to 70 years received a BP cuff and hypertension-related educational materials. Participants were recruited from EDs and other community-based settings in Detroit, Michigan, where they were screened for initial eligibility and enrolled. Baseline data collection and randomization occurred approximately 2 and 4 weeks after enrollment to ensure that participants had uncontrolled hypertension and were willing to take part. Data collection visits occurred at 13, 26, 39, and 52 weeks. Outcomes of interest included BP (primary outcome) and physical activity, sodium intake, medication adherence, and BP control (secondary outcomes). Results We obtained consent from and enrolled 869 participants in this study yet ultimately randomized 162 (18.6%) participants. At 1 year, compared to the baseline, both groups showed significant decreases in systolic BP (MI-BP group: 22.5 mm Hg decrease in average systolic BP and P<.001; control group: 24.1 mm Hg decrease and P<.001) adjusted for age and sex, with no significant differences between the groups (time-by-arm interaction: P=.99). Similar patterns where improvements were noted in both groups yet no differences were found between the groups were observed for diastolic BP, physical activity, sodium intake, medication adherence, and BP control. Large dropout rates were observed in both groups (approximately 60%). Conclusions Overall, participants randomized to both the enhanced usual care control and MI-BP conditions experienced significant improvements in BP and other outcomes; however, differences between groups were not detected, speaking to the general benefit of proactive outreach and engagement focused on cardiometabolic risk reduction in urban-dwelling, low-socioeconomic-status Black populations. High dropout rates were found and are likely to be expected when working with similar populations. Future work is needed to better understand engagement with mobile health interventions, particularly in this population. Trial Registration ClinicalTrials.gov NCT02955537; https://clinicaltrials.gov/study/NCT02955537 International Registered Report Identifier (IRRID) RR2-10.2196/12601


Pilot/feasibility
Fully powered no ms number (yet) / not (yet) submitted to / published in JMIR Other: TITLE AND ABSTRACT 1a) TITLE: Identification as a randomized trial in the title yes Other: subitem not at all important If this is a JMIR submission, please provide the manuscript tracking number under "other" (The ms tracking number can be found in the submission acknowledgement email, or when you login as author in JMIR.If the paper is already published in JMIR, then the ms tracking number is the four-digit number at the end of the DOI, to be found at the bottom of each published article in JMIR) 57863 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"?(if not, explain the reason under "other") 1a-i) Identify the mode of delivery in the title Identify the mode of delivery.Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title.Avoid ambiguous terms like "online", "virtual", "interactive".Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g.email), use "computer-based" or "electronic" only if o�ine products are used.Use "virtual" only in the context of "virtual reality" (3-D worlds).Use "online" only in the context of "online support groups".Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
subitem not at all important Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "The Effect of an mHealth Self-Monitoring Intervention" 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Black Individuals With Uncontrolled Hypertension" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "randomized controlled trial of the MI-BP intervention compared to an enhanced usual care control group where participants aged 25 to 70 years received a BP cuff.Participants were recruited from EDs and other community-based settings in Detroit, Michigan, United States, where they were screened for initial eligibility and enrolled.Baseline data collection and randomization occurred approximately 2 and 4 weeks after enrollment to ensure that participants had uncontrolled HTN and were willing to take part.Data collection visits occurred at 13, 26, 39, and 52 weeks.Outcomes of interest included BP (primary outcome) and physical activity, sodium intake, and medication adherence (secondary outcomes)." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any).(Note: Only report in the abstract what the main paper is reporting.If this information is missing from the main body of text, consider adding it) subitem not at all important Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study This is discussed in more detail in the previously published protocol, which is cited in this manuscript, but revisions due to COVID-19 were also detailed here, "In March 2020, the MI-BP trial was closed to new enrollments and in-person data collection due to the COVID-19 pandemic.This necessitated protocol changes in the following weeks and months in an effort to maximize data collection from participants who were enrolled in the study before the pandemic.To summarize these changes, we pivoted to remote data collection for follow-up assessments via phone or videoconference."

4a-iii) Information giving during recruitment
Information given during recruitment.Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.

Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

Your answer
subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study This is discussed in more detail in the previously published protocol, which is cited in this manuscript, but revisions due to COVID-19 were also detailed here, "In March 2020, the MI-BP trial was closed to new enrollments and in-person data collection due to the COVID-19 pandemic.This necessitated protocol changes in the following weeks and months in an effort to maximize data collection from participants who were enrolled in the study before the pandemic.To summarize these changes, we pivoted to remote data collection for follow-up assessments via phone or videoconference." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

Does your paper address subitem 4b-i? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study This is discussed in more detail in the previously published protocol, which is cited in this manuscript, but revisions due to COVID-19 were also detailed here, "In March 2020, the MI-BP trial was closed to new enrollments and in-person data collection due to the COVID-19 pandemic.This necessitated protocol changes in the following weeks and months in an effort to maximize data collection from participants who were enrolled in the study before the pandemic.To summarize these changes, we pivoted to remote data collection for follow-up assessments via phone or videoconference."

4b-ii) Report how institutional affiliations are displayed
Report how institutional a�liations are displayed to potential participants [on ehealth media], as a�liations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Nota required item -describe only if this may bias results) 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Your answer

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, a�liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con�ict of interest" section or mentioned elsewhere in the manuscript).

Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Your answer

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
subitem not at all important essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Your answer

5-iii) Revisions and updating
Revisions and updating.Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial.Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Your answer

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.

Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Your answer

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org,and/or publishing the source code or screenshots/videos alongside the article).As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Your answer

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered".It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study  Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study not applicable -this is intended to be a stand-alone intervention.
subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study This is discussed in more detail in the previously published protocol, which is cited in this manuscript.but revisions due to COVID-19 were also detailed here, "In March 2020, the MI-BP trial was closed to new enrollments and in-person data collection due to the COVID-19 pandemic.This necessitated protocol changes in the following weeks and months in an effort to maximize data collection from participants who were enrolled in the study before the pandemic.To summarize these changes, we pivoted to remote data collection for follow-up assessments via phone or videoconference." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].

Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text Your answer 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de�ned/ measured/monitored (logins, log�le analysis, etc.).Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.

Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text

Your answer
subitem not at all important 1 2 3 4 5 essential 6b) Any changes to trial outcomes after the trial commenced, with reasons 7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Your answer Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study This is discussed in more detail in the previously published protocol, which is cited in this manuscript.but revisions due to COVID-19 were also detailed here, "In March 2020, the MI-BP trial was closed to new enrollments and in-person data collection due to the COVID-19 pandemic.This necessitated protocol changes in the following weeks and months in an effort to maximize data collection from participants who were enrolled in the study before the pandemic.To summarize these changes, we pivoted to remote data collection for follow-up assessments via phone or videoconference.This meant that home-monitored BP measurements using study-issued cuffs served as the final outcome measures for participants completing their trial participation between March 2020 and April 2021.In addition, as all in-person participant interaction had been suspended, all laboratory measures were discontinued during the COVID-19 pandemic, and survey-based assessments were conducted verbally by phone or videoconference out of concern for literacy levels among participants.We also removed several instruments from interim follow-up assessments in weeks 13 and 39.Finally, anthropometric assessments, including weight, height, and waist circumference measurements, were self-reported by participants using their own home scales and tape measures.Given the increased reliance on homebased, self-reported data, the chance of missing data from follow-up assessments was greater." subitem not at all important 1 2 3 4 5 essential 7b) When applicable, explanation of any interim analyses and stopping guidelines 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

Your answer
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study not applicable for this manuscript as interim analyses were not included in trial design.

Does your paper address CONSORT subitem 8a? *
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Your answer 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study This is not applicable for this manuscript and intervention Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Descriptive statistics were calculated for demographic variables and baseline measures.To ensure balance across study arms, these measures were compared using t tests, Wilcoxon rank sum tests, or chi-square tests, as appropriate.Linear mixed models were used to investigate differences in change in the outcomes between study arms, with time, study arm, and their interaction as primary covariates.For all outcomes, time was entered as a categorical covariate.The models were further adjusted for age and sex.For the BP outcomes (SBP and DBP), a second set of models was explored, where time was entered as a linear term to capture the rate of change in the outcomes.All models included a random intercept to account for intrasubject correlation.Square root transformations were used to the International Physical Activity Questionnaire-Short Form (IPAQ-SF) and BSS, and a log transformation was applied to the ARMS-14 before running the linear mixed models to better meet model assumptions.
To investigate whether dropout was associated with any covariates, a time-to-dropout analysis was carried out using a Cox regression model.As this study was partially conducted during the COVID-19 pandemic, we wanted to consider the impact of COVID-19 on dropout.Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Descriptive statistics were calculated for demographic variables and baseline measures.To ensure balance across study arms, these measures were compared using t tests, Wilcoxon rank sum tests, or chi-square tests, as appropriate.Linear mixed models were used to investigate differences in change in the outcomes between study arms, with time, study arm, and their interaction as primary covariates.For all outcomes, time was entered as a categorical covariate.The models were further adjusted for age and sex.For the BP outcomes (SBP and DBP), a second set of models was explored, where time was entered as a linear term to capture the rate of change in the outcomes.All models included a random intercept to account for intrasubject correlation.Square root transformations were used to the International Physical Activity Questionnaire-Short Form (IPAQ-SF) and BSS, and a log transformation was applied to the ARMS-14 before running the linear mixed models to better meet model assumptions.

X26-i) Comment on ethics committee approval
Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Outline informed consent procedures e.g., if consent was obtained o�ine or online (how?Checkbox, etc.?), and what information was provided (see 4a-ii).See [6] for some items to be included in informed consent documents.

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Your answer

X26-iii) Safety and security procedures
Safety and security procedures, incl.privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Your answer 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "In total, we prescreened 12,451 individuals, predominantly in ED settings (n=12,089, 97.09% in EDs; n=169, 1.36% from community events; and n=193, 1.55% from mobile health units), of whom 1195 (9.6%) were preliminarily eligible for participation.Of those 1195 participants, 869 (72.72%) were consented and enrolled in this study.Most enrolled participants were excluded after enrollment (before randomization) for failing the secondary screening in the ED, not meeting the inclusion criteria at baseline, or not meeting the primary inclusion criteria after consent (243/869, 28%); lost to follow-up before randomization (416/869, 47.9%); or scheduled for baseline or randomization visits that were halted due to the COVID-19 pandemic (48/869, 5.5%).Figure 1 shows the CONSORT (Consolidated Standards of Reporting Trials) diagram of participant flow through the trial.Due to the COVID-19 pandemic, in March 2020, ED recruitment for the trial was suspended precluding new enrollments from the ED.While we were able to eventually transition to community-based recruitment using mobile units under an IRB-approved protocol amendment within 9 months of this, screening was severely reduced, and no new randomizations occurred.These considerations, combined with the challenge of keeping participants engaged using remote follow-up, prompted a decision by the study team, made in conjunction with our DSMB, to end recruitment for this study in January 2022.Ultimately, we randomized 162 participants to the MI-BP trial." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram)

*
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "In total, we prescreened 12,451 individuals, predominantly in ED settings (n=12,089, 97.09% in EDs; n=169, 1.36% from community events; and n=193, 1.55% from mobile health units), of whom 1195 (9.6%) were preliminarily eligible for participation.Of those 1195 participants, 869 (72.72%) were consented and enrolled in this study.Most enrolled participants were excluded after enrollment (before randomization) for failing the secondary screening in the ED, not meeting the inclusion criteria at baseline, or not meeting the primary inclusion criteria after consent (243/869, 28%); lost to follow-up before randomization (416/869, 47.9%); or scheduled for baseline or randomization visits that were halted due to the COVID-19 pandemic (48/869, 5.5%).Figure 1 shows the CONSORT (Consolidated Standards of Reporting Trials) diagram of participant flow through the trial.Due to the COVID-19 pandemic, in March 2020, ED recruitment for the trial was suspended precluding new enrollments from the ED.While we were able to eventually transition to community-based recruitment using mobile units under an IRB-approved protocol amendment within 9 months of this, screening was severely reduced, and no new randomizations occurred.These considerations, combined with the challenge of keeping participants engaged using remote follow-up, prompted a decision by the study team, made in conjunction with our DSMB, to end recruitment for this study in January 2022.Ultimately, we randomized 162 participants to the MI-BP trial." subitem not at all important 1 2 3 4 5 essential 14a) Dates defining the periods of recruitment and follow-up subitem not at all important Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other �gures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the �gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

Your answer
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study This was also noted in our prior published protocol paper, but also noted here, "These considerations, combined with the challenge of keeping participants engaged using remote follow-up, prompted a decision by the study team, made in conjunction with our DSMB, to end recruitment for this study in January 2022.Ultimately, we randomized 162 participants to the MI-BP trial." 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi�cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 14b) Why the trial ended or was stopped (early) Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Table 1 shows participant characteristics as well as summary baseline measures stratified by study arm.

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide de�nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci�c pre-de�ned time points of interest (in absolute and relative numbers per group).Always clearly de�ne "use" of the intervention.
Does your paper address subitem 16-i?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Table 1 shows participant characteristics as well as summary baseline measures stratified by study arm.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

Your answer
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Table 2. Estimated pairwise mean differences and SEs across time for systolic blood pressure by study arm."and "Table 3.Estimated pairwise mean differences and SEs across time for diastolic blood pressure by study arm." 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de�nitions is critical.This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length".These must be accompanied by a technical description how a metric like a "session" is de�ned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Your answer

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded.Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error.Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i?* Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study See the robust Limitations section in this manuscript."Perhapsthe largest limitation was the undeniable negative impact of the COVID-19 pandemic, which caused us to stop study recruitment early and likely had significant effects on trial participation for those who were already randomized to the study.Combined with a high dropout rate, early study termination led to an underpowered study, which may have caused us to be unable to find significant differences between the groups." subitem not at all important Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (�nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/ evaluators are distinct from or identical with the developers/sponsors of the intervention.Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study

Your answer
As a result of using this checklist, did you make changes in your manuscript?* What were the most important changes you made as a result of using this checklist?
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essential
Is this a full powered effectiveness trial or a pilot/feasibility trial?* Manuscript tracking number * address subitem 1a-i?* ) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii?* Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract.If possible, also mention theories and principles used for designing the site.Keep in mind the needs of systematic reviewers and indexers by including important synonyms.(Note: Only report in the abstract what the main paper is reporting.If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-i?*

essential
Does your paper address subitem 1b-ii?

essential
Does your paper address CONSORT subitem 4b? *

5
-xii) Describe any co-interventions (incl.training/support) Describe any co-interventions (incl.training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention.This includes training sessions and support [1].It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.Does your paper address subitem 5-xii?* address CONSORT subitem 6a? * each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center x26-ii) Outline informed consent procedures number and name of trial registry 21-i) Generalizability to other populations Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * 2 hours were spent in this process As a result of using this checklist, do you think your manuscript has improved?* yes no Other:

Final step :
Click submit !Click submit so we have your answers in our database!Never submit passwords through Google Forms.This form was created outside of your domain.Report Abuse -Terms of Service -Privacy Policy Would you like to become involved in the CONSORT EHEALTH group?This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" documentAny other comments or questions CONSORT EHEALTHYour answer Forms Mention how participants were recruited (online vs. o�ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment).Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials).Note: In traditional o�ine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered.To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e.participants can self-enrol).(Note: Only report in the abstract what the main paper is reporting.If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons.(Note: Only report in the abstract what the main paper is reporting.If this information is missing from the main body of text, consider adding it) your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "we sought to develop and test an mHealth intervention (MI-BP).The MI-BP intervention was developed with the intention of educating and supporting self-monitoring of multiple health behaviors to reduce BP among Black individuals with uncontrolled HTN recruited from urban EDs and community-based settings."2a-ii)Scientificbackground, rationale: What is known about the (type of) system Scienti�c background, rationale: What is known about the (type of) system that is the object of the study (be sure to discuss the use of similar systems for other conditions/ diagnoses, if appropiate), motivation for the study, i.e. what are the reasons for and what is the context for this speci�c study, from which stakeholder viewpoint is the study performed, potential impact of �ndings[2].Brie�y justify the choice of the comparator.
Does your paper address subitem 2a-ii?*Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "...BP can typically be well controlled through lifestyle and behavior changes.Recommendations for managing HTN have been consistent for decades and center on positive health behaviors such as maintaining a healthy weight, reducing daily sodium intake, increasing physical activity, and adhering to prescribed antihypertensive therapies[11]; however, engaging in these behaviors is difficult for many individuals, and this is especially true in Black individuals, who are less likely than White individuals to report adherence to preventive behaviors " "We hypothesized that (1) mean systolic BP (SBP) would be significantly lower in the MI-BP arm than in the control group after 1 year (hypothesis 1) and (2) measures of physical activity, sodium intake, and medication adherence would be significantly better in the MI-BP arm than in the control arm after 1 year (hypothesis 2)." Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing �owcharts of the algorithms used.Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti�c reporting.
Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci�c group.If known, describe how participants obtained "access to the platform and Internet" [1].To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study This is discussed in more detail in the previously published protocol, which is cited in this manuscript.Describe use parameters (e.g., intended "doses" and optimal timing for use).Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework Describe mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework [6] used to design them (instructional strategy [1], behaviour change techniques, persuasive features, etc., see e.g.,[7, 8]for terminology).This includes an in-depth description of the content (including where it is coming from and who developed it) [1]," whether [and how] it is tailored to individual circumstances and allows users to track their progress and receive feedback"[6].This also includes a description of communication delivery channels and -if computer-mediated communication is a component -whether communication was synchronous or asynchronous[6].It also includes information on presentation strategies [1], including page design principles, average amount of text on pages, presence of hyperlinks to other resources, etc. [1].This is discussed in more detail in the previously published protocol, which is cited in this manuscript.
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc.It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study This is discussed in more detail in the previously published protocol, which is cited in this manuscript.
essential 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 5-xi) Report any prompts/reminders used Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Trial randomization was stratified by sex in blocks of equal size.Study staff responsible for arm allocation were blinded to block size to prevent contamination."Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Specify who was blinded, and who wasn't.Usually, in web-based trials it is not possible to blind the participants[1, 3](this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any).
"Trial randomization was stratified by sex in blocks of equal size.Study staff responsible for arm allocation were blinded to block size to prevent contamination."Doesyourpaper address CONSORT subitem 10? *Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Blinding is not applicable for this study.
To that end, we defined a new variable, "COVID group," for each individual at each time point.If the event time (eg, week 13) of individual assessments was before 3 PM on March 16, 2020, we considered these records as "before COVID-19."Otherwise,weconsideredtherecords as "During COVID-19."Thus,theCOVID-19groupwas modeled as a time-dependent covariate in the Cox model.All statistical analyses were carried out in SAS (version 9.4; SAS Institute)."Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials.Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic[4]).Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "To investigate whether dropout was associated with any covariates, a time-to-dropout analysis was carried out using a Cox regression model.As this study was partially conducted during the COVID-19 pandemic, we wanted to consider the impact of COVID-19 on dropout.To that end, we defined a new variable, "COVID group," for each individual at each time point.If the event time (eg, week 13) of individual assessments was before 3 PM on March 16, 2020, we considered these records as "before COVID-19."Otherwise, we considered the records as "During COVID-19."Thus, the COVID-19 group was modeled as a time-dependent covariate in the Cox model.All statistical analyses were carried out in SAS (version 9.4; SAS Institute)."" To investigate whether dropout was associated with any covariates, a time-to-dropout analysis was carried out using a Cox regression model.As this study was partially conducted during the COVID-19 pandemic, we wanted to consider the impact of COVID-19 on dropout.To that end, we defined a new variable, "COVID group," for each individual at each time point.If the event time (eg, week 13) of individual assessments was before 3 PM on March 16, 2020, we considered these records as "before COVID-19."Otherwise, we considered the records as "During COVID-19."Thus, the COVID-19 group was modeled as a time-dependent covariate in the Cox model.All statistical analyses were carried out in SAS (version 9.4; SAS Institute)." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "These considerations, combined with the challenge of keeping participants engaged using remote follow-up, prompted a decision by the study team, made in conjunction with our DSMB, to end recruitment for this study in January 2022.Ultimately, we randomized 162 participants to the MI-BP trial." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Table2.Estimated pairwise mean differences and SEs across time for systolic blood pressure by study arm."and"Table3.Estimated pairwise mean differences and SEs across time for diastolic blood pressure by study arm."Copyand paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Table4.Time-to-dropout results based on Cox regression model." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "AEs for this trial were all determined to be cardiovascular in nature.A total of 15 AEs of SBP>180 were reported.All were determined to be unrelated to the study, and all were reported to both the WSU IRB and the study DSMB.In addition, during the course of this trial, 3 serious AEs (SAEs) were reported by research participants.All 3 SAEs were determined to be unexpected and unrelated to the MI-BP intervention, and all 3 patients recovered with treatment.SAEs reported in this trial included 2 instances of non-ST-elevation myocardial infarction and 1 instance of cerebral visual impairment.All SAEs were reported to both the WSU IRB and the study DSMB."19-i)Includeprivacybreaches,technicalproblemsIncludeprivacy breaches, technical problems.This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents."Unintendedeffects"alsoincludesunintended positive effects[2].Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Results from this study suggest that, compared to our enhanced usual care control group, the MI-BP intervention did not have any significant effects on participants in this study, including the primary outcome measure of BP or the secondary outcome measures of physical activity, sodium intake, and medication adherence." Your answer 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other cointerventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study Your answer 24) Where the full trial protocol can be accessed, if available 25) Sources of funding and other support (such as supply of drugs), role of funders X27) Conflicts of Interest (not a CONSORT item)Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "Trial Registration: ClinicalTrials.govNCT02360293"Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study https://www.researchprotocols.org/2019/1/e12601/Doesyour paper address CONSORT subitem 25? *Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie�y explain why the item is not applicable/relevant for your study "This study was funded by the National Heart, Lung, and Blood Institute at the National Institutes of Health (1R01HL127215-01A1)"